TrialDox Blog – Accelerating clinical trials…

Can personal health records (PHRs) revolutionize the clinical trial industry?  In our opinion: Yes.  We’re interested in what you think, as well.

To foster a discussion to solicit your opinion, find below a primer on PHR and what the public and private sector are doing to promote PHRs.

What are PHRs?

PHR is a patient-controlled document of his or her health information in a format of his or her choice.  (A medical health record, by contrast, is patient health information controlled by a physician, healthcare institution or health insurance company.)  Information documented in a PHR can be as limited as emergency health information to facilitate emergent care or as broad as all provider visits, diagnostic records, prescriptions, and health insurance information.  Storage formats can range from a local computer hard drive, portable hard drive, or internet-based subscription service.

Public sector PHR activity

Medicare (Centers for Medicare & Medicaid Services), since 2006, has undertaken several pilot programs to encourage the use of PHRs.  For more about Medicare pilots, click here.  A number of policy recommendations have been made by the National Coordinator of Health Information Technology.

Certification Commission for Health Information Technology (CCHIT) has assembled a special PHR Advisory Task Force and created an associated workgroup in order to draft a set of certification criteria for PHRs. The certification criteria, which are scheduled for release by 2010, will place an emphasis on industry privacy safeguards while also addressing security and interoperability issues. For more information, click here.

A number of states have introduced legislation to govern the usage of PHRs.  For a survey of state-level legislation, see the National Conference of State Legislatures tracking by clicking here.

Private sector PHR activity

A list of players in the PHRs:

• CapMed.com
• Microsoft HealthVault
• Caregiver Alliance Web Services
• MiVia
• CEND-PHR
• MyGroupHealth (Group Health Cooperative)
• Collaborative Family Health Record
• MyHealtheVet (U.S. Department of Veterans Affairs)
• Dossia
• MyHIN
• FollowMe
• MyMedicalRecords.com
• Google Health
• Myphr.com
• HealthAtoZ
• Patient Gateway (Partners HealthCare)
• iHealthRecord.com
• PatientSite (Beth Israel Deaconess Medical Center)
• LifeOnKey
• RecordsForLiving.com
• Med Alert
• e-Healthkey
• Revolution Health Group
• MedCommons
• VitalChart

While not meant to be exhaustive, the list above suggests that policy announcements have encouraged a proliferation of private sector offerings in the PHR space.  For a more exhaustive list, visit myPHR.  In addition, several non-profit organizations have initiated studies to evaluate standards to optimize interoperability, security and data modification (see Robert Wood Johnson Foundation, PDF).

Opportunity for clinical trials

The “low-handing fruit” for science and clinical research, in our opinion, lies in the intersection of PHRs and these core areas:

• Analysis of diagnostic data for patient identification for clinical trial recruitment
• Self-identification for clinical trial recruitment
• Analysis of historical records for hypothesis creation

Interested in your opinions…

Perhaps the lowest of the “low-hanging fruit” in clinical trial document management efficiencies is in transitioning existing records management systems and signatures to an electronic platform. The FDA under part 11 of Title 21 of the Code of Federal Regulations describes guidelines in maintaining and submitting such electronic information to the FDA.

Under part 11, the FDA specifies that the following requirements will be enforced:

• Limiting system access to authorized individuals
• Use of operational system checks
• Use of authority checks
• Use of device checks
• Determination that persons who develop, maintain or use electronic systems have adequate training
• Establishment of policies that hold persons accountable for actions initiated under electronic signatures
• Controls for open systems
• Requirements related to electronic signatures

While this post is not meant to offer guidance on how to meet the above requirements (**disclaimer**), the following attributes that should be present to meet the above requirements are described here in summary as a reference, and should be thoroughly reviewed at the FDA website (here and here).

For electronic records:

• Portable electronic formats: Use an industry standard portable format that allows export and retrieval upon inspection.
• Retention: Archived records must be retrievable.
• Audit trails: Record operator actions in creating, editing, deleting records that affect GxP records.
• Security: Follow existing international security standards such as ISO/IEC.

For electronic signatures:

• System controls: Workflows, procedures, system design ensures verification.
• Signature controls: Use at least two identification controls (eg, username and password).
• Password controls: Rigorous rules, expiration and encryption.

A great reference: 21CFRPart11.com.

What are your experiences and challenges in meeting 21 CFR Part 11 guidelines?